MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION

Model Number	M3015A
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to philips that their co2 microstream extension module had a broken latch and was dropped because of the damaged latch.No patient involvement.

• Brand Name: MICROSTREAM CO2 EXTENSION
• Common Device Name: MICROSTREAM CO2 EXTENSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9470928
• Report Number: 9610816-2019-00332
• Device Sequence Number: 2449443
• Product Code: DSI
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K993383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3015A
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1